FDA Adverse Event Injury Summary report: N

AMISTEM H HA COATED STD STEM SIZE 2

MDR report key: 8636374 · Received May 23, 2019

Report

Report Number: 3005180920-2019-00403
Event Type: Injury
Date Received: May 23, 2019
Date of Event: May 1, 2019
Report Date: May 23, 2019
Manufacturer: MEDACTA INTERNATIONAL SA
Product Code: LZO
UDI-DI: 07630030804083
PMA / PMN Number: K093944
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: IL, US
Reporter Occupation: 003

Narratives

Additional Manufacturer Narrative · 1

BATCH REVIEW PERFORMED ON 20 MAY 2019. LOT 161461: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 16-JUN-2016. EXPIRATION DATE: 2021-05-24. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT. CLINICAL EVALUATION PERFORMED BY MEDICAL AFFAIRS DEPARTMENT PARTIAL HIP REVISION SURGERY OCCURRED 2, 5 YEARS AFTER CEMENTLESS TOTAL HIP ARTHROPLASTY. NO INFORMATION CONCERNING PATIENT AGE, ACTIVITY LEVEL OR COMORBIDITIES IS AVAILABLE. RADIOGRAPHIC IMAGE PROVIDED SHOWS THE PRESENCE OF RADIOLUCENT LINES AND OSTEOLYTIC REGIONS AROUND THE STEM AND SIGNS OF STRESS SHIELDING. ASEPTIC LOOSENING IS A POSSIBLE LITERATURE DESCRIBED ADVERSE EVENT AFER CEMENTLESS TOTAL HIP ARTHROPLASTY AND CAUSES ARE OFTEN UNKNOWN. THE REASON OF THIS EVENT CANNOT BE DETERMINED.

Description of Event or Problem · 1

ABOUT 2 YEARS AND 6 MONTHS AFTER PRIMARY SURGERY, THE SURGEON REVISED THE PATIENT STEM, CERAMIC HEAD AND LINER FOR A STEM POTTING. THE SURGERY WAS COMPLETED SUCCESSFULLY. ON (B)(6) WE WERE INFORMED ABOUT THE EVENT AND THE REVISION SURGERY WAS PERFORMED ON (B)(6) 2019.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
430948	AMISTEM H HA COATED STD STEM SIZE 2	HIP CEMENTLESS STEM	LZO	MEDACTA INTERNATIONAL SA		161461	07630030804083

Patients

Seq	Age	Sex	Outcome	Treatment
1			Required Intervention